Skip to main content
OpenTrials
Completed

NCT Number: NCT03447964

Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes

Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

About this study

Sphingolipids represent a major class of lipids that are structural and signaling molecules. Major bioactive sphingolipids include ceramide, dihydroceramide, sphingosine, sphingosine-1-phosphate and sphingomyelin.

Sphingoliplids are involved in development of various chronic metabolic diseases. Some ceramides species are implicated in pancreatic β-cell apoptosis and in insulin resistance in muscle, fat and liver. Some studies have shown association between inhibition of ceramide synthesis, insulin sensibility and lower hepatic steatosis. The deposition of hepatic lipids, especially triacylglycerol, defines the development of hepatic steatosis. However, sphingolipids appear to play an important role in non-alcoholic fatty liver disease (NAFLD) and in its progression. Changes in plasma shingolipids concentrations may also contribute to the pathogenesis in cardiovascular disease and atherosclerosis. Distribution of plasma sphingolipids concentrations in type 1 and type 2 diabetes has poorly been studied.

The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 or 2 diabetes

Exclusion criteria

  • atypical diabetes
  • family dyslipidemia
  • nonmetabolic hepatopathy
  • severe renal failure
  • corticosteroid or immunosuppressive therapy

Treatment and study plan

dosing of sphingolipids

Other
  • Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine

Primary outcomes

  1. Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

Secondary outcomes

  1. - Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  2. - - Comparison of plasma total sphingomyelins concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  3. - Comparison of plasma total sphingosine concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  4. - Comparison of plasma ceramide species (C16, C18, C20, C22, C23, C24, C24:1, C26:1, C26:2 ceramides) concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  5. - Comparison of plasma dihydroceramide species (C18/16, C18/18, C18/20, C18/22, C18/23, C18/24, C18/24:1, C18/26:1, C18/26:2 dihydroceramides) concentration in type 2 diabetic patients versus type 1 diabetic patients.

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  6. - Correlation between sphingolipids species concentrations and NAFLD biomarkers (steatotest, NASHtest and fibrotest)

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  7. - Correlation between sphingolipids species concentrations and insulin resistance (HOMA-IR)

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  8. - Correlation between sphingolipids species concentrations and microvascular complications (history of retinopathy, nephropathy and neuropathy)

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

  9. - Correlation between sphingolipids species concentrations and macrovascular complications (cardiovascular disease history)

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

    Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content. The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: CERADIAB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.